FDA 510(k) Application Details - K150032

Device Classification Name Tissue Adhesive For The Topical Approximation Of Skin

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510(K) Number K150032
Device Name Tissue Adhesive For The Topical Approximation Of Skin
Applicant GLUSTITCH, INC.
#307-7188 PROGRESS WAY
DELTA V4G 1M6 CA
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Contact DON BLACKLOCK
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Regulation Number 878.4010

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Classification Product Code MPN
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Date Received 01/08/2015
Decision Date 01/14/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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